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follow up of Effects of Melatonin on Fatigue Associated associated with radiotherapy and chemotherapy

Phase 2
Conditions
Breast Cance
Cancer Related Fatigue
Melatonin.
Malignant neoplasm of breast
Registration Number
IRCT20180426039421N3
Lead Sponsor
Hamedan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
64
Inclusion Criteria

Breast Cancer Stages I, II, III According to Pathological Reports
Patients at least 18 Years Old
Have Signed a Written Consent
Recevieng Adjuvant Chemotherapy and Radiotherapy
No Untreated Hypercalcemia
No Systolic Blood Pressure Less Than 100 mm Hg
No Warfarin Consumption
No Methylphenidate Consumption
No Sleep Pills During Melatonin Use
No TSH>5/5 or <0/5
No Pregnancy or Breastfeeding

Exclusion Criteria

Not signing a written consent

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fatigue severity in the BFI questionnaire. Timepoint: 2 years after last adjuvant treatment session. Method of measurement: Brief Fatigue Inventory( BFI) questionnaire.
Secondary Outcome Measures
NameTimeMethod
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